复方曲氯乳膏的制备及质量控制

Preparation and Quality Control of Compound Qulu Cream

目的：制备复方曲氯乳膏并建立其质量可控方法。方法：以醋酸曲安奈德和氯霉素为主药制备乳膏，用高效液相色谱法测定2主药的含量。结果：醋酸曲安奈德和氯霉素检测浓度线性范围分别为3．116～46．74μg／m[（r=0．9999）、51．32～975．08μg／ml（r=0．9999），平均回收率分别为100．50％、101．50％，RSD分别为1．18％（n=5）、0．70％（n=5）。结论：复方曲氯乳膏制备方法简便，性质稳定，质量可控。

OBJECTIVE： To prepare compound qulu cream and to establish its quality control method. METHODS： The cream was prepared with triamcinolone acetonide acetate and chloramphenicol as the principal agents, the contents of which were determined by HPLC. RESULTS： The respective linear concentration range of triamcinolone acetonide acetate and chloramphenicol was 3.116 - 46.74μg/ml （r = 0.9 999, n = 5） and 51.32 - 975.08 μg/ml （r = 0.9 999, n = 5）, and the respective average recovery of which was 100.50% （RSD ： 1.18%, n = 5） and 101.50% （RSD ： 0.70%, n = 5）. CONCLUSIONS： The cream is simple in preparation, stable in quality, accurate and reliable in assaying method.